POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA— 510(k) K990812
Substantially EquivalentAmpri Rubberware Industries Sdn Bhd
FDA 510(k) clearance K990812 for POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA, Substantially Equivalent on 1999-05-04. Applicant: Ampri Rubberware Industries Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Ampri Rubberware Industries Sdn Bhd
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Batang Kali, Selangor, MY
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More clearances from Ampri Rubberware Industries Sdn Bhd
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